NCT00345098

A Study of SR58611A in the Prevention of Depression Relapse in Patients With Major Depressive Disorder

A Double-Blind, Multi-Center, Multinational, Randomized Withdrawal Study Evaluating the Efficacy and Safety of SR58611A (350mg q12) Versus Placebo in the Prevention of Depression Relapse up to 1 Year in Patients With Major Depressive Disorder Improved After 12 Weeks of Open Treatment With SR58611A (350mg q12)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 704 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess whether treatment with SR58611A can prevent relapse of depressive symptoms in patients with major depressive disorder. Relapse will be assessed using the MADRS scale.Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with SR58611A are randomized to continue SR58611A or switch to placebo under double blind conditions for up to 52 weeks of additional treatment. The secondary objective is to evaluate the safety of SR58611A in patients with MDD.

Conditions

• Depressive Disorder
• Major Depression

Interventions

Type	Name	Description
DRUG	SR58611A

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2006-06-27
• Last updated: 2009-03-12

Locations

13 sites across 13 countries: Argentina, Bulgaria, Croatia, Czechia, Finland, France, Mexico, Poland, Romania, Russia, Serbia, Slovakia, South Africa